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The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold surgical instruments in a given position and to change that position immediately with one hand.
The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold manual surgical instruments and the SaphLite Retractor in a given position and to change that position immediately with one hand.

The SAPHLIFT consists of three main components: an articulated arm that clamps to the rail of the surgical bed, an instrument holder, and a compressed gas supply to maintain the pneumatic pressure to hold the instrument in place. Ball joints in the articulated arm and instrument holder allow for a wide variety of instrument positions. Repositioning of the instrument is by means of a control lever that releases the pneumatic pressure when pressed and locks the instrument in place when released. The SAPHLIFT is reusable and is sterilized by steam autoclave.

The provided document is a 510(k) summary for a surgical instrument holder called SAPHLIFT. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence rather than performance studies with defined acceptance criteria.

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